Prospective Evaluation Assessing U2 MB™ Total Knee System
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age21+
SponsorMSK Doctors & Associates Ltd
About this trial
The goal of this study is to evaluate the safety and effectiveness of the United Orthopaedics Mobile Bearing Total Knee System (U2 MB™ Knee) in patients undergoing total knee replacement surgery due to end-stage knee osteoarthritis. The main questions it aims to answer are:
1\. What is the component survivorship of the U2 MB™ Knee system at 1, 3, 5, and 10 years?
Participants will:
1. Return for follow-up assessments at Year 1, Year 3, Year 5, and Year 10 after surgery 2. Undergo clinical evaluations including functional outcome scoring, radiographic imaging.
This study will take place across three investigational sites and will involve 150 knee replacements using U2 MB™ components. The study's objectives include assessing early to long-term outcomes in terms of implant survivorship, clinical function, patient satisfaction, radiological findings, and overall safety of the device over a 10-year period.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
All patients suitable for a cemented Total Knee Replacement, MBC design
All elective pathology (including Osteoarthritis, Rheumatoid arthritis, Post-traumatic arthritis not requiring stemmed components, Avascular necrosis)
Willing to voluntarily sign the informed consent form
Willing and able to comply with the protocol, able to read and complete the required forms, and willing and able to adhere to the requirements of the protocol through the 10-year postoperative follow-up visit.
Disqualifiers
Skeletally immature (less than 21 years of age) at time of implantation
Active native knee joint infection
Post-traumatic arthritis requiring stemmed components
Malignancy around the knee
Trial population
Clinic
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
150 Participants
are grouped into 1 trial groupGroup A: Knee implant group
Trial outcomes
Primary outcomes
1
Study of the survivorship of the U2 MB™ Knee system and its components, defined as no removal or revision of any components during a 10-year interval after implantation.
Time frame
10 yearsSecondary outcomes
1
Two standardized scores will grade the functional score of the knee joint over time: Knee Society Score (KSS) and Oxford Knee Score (OKS)
Time frame
10 yearsLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
MSK Doctors & Associates Ltd
Lead sponsor
United Orthopedics Inc.
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: